Annuloplasty instrument

ABSTRACT

A device for repairing a heart valve comprises an implantation instrument. The implantation instrument comprises a first support ring, and a second support ring connected to said first support ring to form a coiled configuration. The first support ring is configured to abut one side of the valve and the second support ring is configured to abut an opposite side of the valve to thereby trap a portion of the valve tissue therebetween. The device further comprises an annuloplasty implant adapted to be attached to the heart valve annulus in order to reshape the annulus and allow the leaflets to open and close properly. The annuloplasty implant is connected to the implantation instrument for insertion to the annulus.

This application is a continuation-in-part of application Ser. No.10/787,581, filed on Feb. 26, 2004 now U.S. Pat. No. 6,964,684 (pending)which is a divisional of application Ser. No. 10/145,416 filed on May14, 2002 (now U.S. Pat. No. 6,730,121) which is a divisional ofapplication Ser. No. 09/610,784 filed Jul. 6, 2000 (now U.S. Pat. No.6,419,696), the disclosures of which are fully incorporated herein byreference.

FIELD OF THE INVENTION

The present invention generally relates to heart valve repair andreplacement techniques and annuloplasty devices. More specifically, theinvention relates to the repair of heart valves having variousmalformations and dysfunctions.

BACKGROUND OF THE INVENTION

Diseased mitral and tricuspid valves frequently need replacement orrepair. The mitral and tricuspid valve leaflets or supporting chordaemay degenerate and weaken or the annulus may dilate leading to valveleak (insufficiency). The leaflets and chords may become calcified andthickened rendering them stenotic (obstructing forward flow). Finally,the valve relies on insertion of the chordae inside the ventricle. Ifthe ventricle changes in shape, the valve support may becomenon-functional and the valve may leak.

Mitral and tricuspid valve replacement and repair are traditionallyperformed with a suture technique. During valve replacement, sutures arespaced around the annulus (the point where the valve leaflet attaches tothe heart) and then the sutures are attached to a prosthetic valve. Thevalve is lowered into position and when the sutures are tied, the valveis fastened to the annulus. The surgeon may remove all or part of thevalve leaflets before inserting the prosthetic valve. In valve repair, adiseased valve is left in situ and surgical procedures are performed torestore its function. Frequently an annuloplasty ring is used to reducethe size of the annulus. The ring serves to reduce the diameter of theannulus and allow the leaflets to oppose each other normally. Suturesare used to attach a prosthetic ring to the annulus and to assist inplicating the annulus.

In general, the annuloplasty rings and replacement valves must besutured to the valve annulus and this is time consuming and tedious. Ifthe ring is severely malpositioned, then the stitches must be removedand the ring repositioned relative to the valve annulus duringrestitching. In other cases, a less than optimum annuloplasty may betolerated by the surgeon rather than lengthening the time of the surgeryto restitch the ring.

During heart surgery, a premium is placed on reducing the amount of timeused to replace and repair valves as the heart is frequently arrestedand without perfusion. It would therefore be very useful to have amethod to efficiently attach a prosthesis into the mitral or tricuspidvalve position.

SUMMARY OF THE INVENTION

It is an object of the invention to provide a more reliable and moreeasily accomplished valve repair. It is a specific object of theinvention to facilitate insertion of an annuloplasty implant.

These and other objects of the invention are accomplished by means of adevice, a kit and a method according to the independent claims.Preferred embodiments of the invention are apparent from the dependentclaims.

Thus, according to a first aspect of the invention, a device is providedfor repairing a heart valve comprised of valve tissue including anannulus and a plurality of leaflets for allowing and preventing bloodflow through a patient's heart. The device comprises an implantationinstrument, which comprises a first support ring, and a second supportring connected to the first support ring to form a coiled configuration.The first support ring is configured to abut one side of the valve andthe second support ring is configured to abut an opposite side of thevalve to thereby trap a portion of the valve tissue, that is, annulustissue and/or leaflet tissue, therebetween. The device further comprisesan annuloplasty implant adapted to be attached to the heart valveannulus in order to reshape the annulus and allow the leaflets to openand close properly.

The implantation instrument is applied to the heart valve in a mucheasier manner than conventionally utilized annuloplasty rings. By meansof the implantation instrument it is possible to fixate the valveannulus and primarily reshape it. This primary reshaping of the valveannulus facilitates attachment of the annuloplasty implant to the valveannulus. There is merely a need for a slight further reshaping of thevalve annulus by the attachment of the annuloplasty implant in order toachieve the desired shape of the valve annulus. Since the attachment ofthe annuloplasty implant need not dramatically change the shape of thevalve annulus, the possibility of correctly positioning the annuloplastyimplant is greatly increased. This implies that there is a very slimrisk that the annuloplasty implant will need to be repositioned.Further, by means of the device the desired reshaping of the valveannulus may in most cases be achieved.

The invention contemplates various embodiments of the device, includingembodiments for catheter-based surgery and embodiments for open heartsurgery.

The first and second support rings may have generally triangular-shapedcross sections with flat sides opposing one another and trapping valvetissue therebetween.

At least the opposed surfaces of the first and second support rings maybe roughened, such as by the use of fabric, coatings, knurling or thelike to facilitate better engagement and retention of the support ringson the valve tissue. The opposed surfaces may be roughened in a patternextending along the longitudinal direction of the rings. This impliesthat the roughened surface will serve to prevent slippage of tissuethrough the ring while presenting a low friction for the ring to beturned into position abutting the valve. The implantation instrument mayhave an inherent shape where the first and second rings contact ornearly contact each other. Thus, the implantation instrument willpresent a spring force pushing the first and second rings towards eachother. The spring force will make the first and second rings fixatingvalve tissue between them.

Preferably, the first and second support rings are formed integrallyfrom a coiled rod, such as a metallic rod, with one end of the rodformed as a leading end and one end formed as a trailing end. These endsmay be bent in opposite directions so that the leading end may bedirected through the valve tissue and the trailing end may be grasped byan appropriate surgical implement. A carrier may be used to rotate theimplantation instrument into position on opposite sides of the valveannulus. As another alternative, the carrier may be coil-shaped and theimplantation instrument may be rotated into place on only one side ofthe valve annulus similar to conventional rings. The carrier may also berotated in opposite direction for withdrawing the implantationinstrument. The first and second support rings may be adjustable indiameter to allow adjustment of the valve annulus.

The annuloplasty implant may have an arcuate shape conforming to adesired arcuate shape of a portion of the annulus. The annuloplastyimplant may then be attached to the portion of the valve annulus forreshaping the valve annulus. The desired reshaping of the valve annulusmay be achieved by the annuloplasty implant reshaping only a portion ofthe valve annulus. Thus, the annuloplasty implant may be C- or U-shaped.The annuloplasty implant may alternatively have a ring-shape conformingto the desired shape of the annulus. The annuloplasty implant may thusbe attached to the valve annulus forcing it to assume the desired shape.

The annuloplasty implant may be removably attached to the second supportring of the implantation instrument. The annuloplasty implant may thenbe detached from the implantation instrument after being attached to thevalve annulus. The implantation instrument may thereafter be removedfrom the patient. The annuloplasty implant may be attached to the secondsupport ring by means of a removable suture. The suture may be cut inorder to detach the annuloplasty implant from the implantationinstrument.

According to a second aspect of the invention, a kit is provided forrepairing a heart valve comprised of valve tissue including an annulusand a plurality of leaflets for allowing and preventing blood flow. Thekit comprises an implantation instrument, which comprises a firstsupport ring, and a second support ring connected to the first supportring to form a coiled configuration. The first support ring isconfigured to abut one side of the valve and the second support ring isconfigured to abut an opposite side of the valve to thereby trap aportion of the valve tissue therebetween. The kit further comprises anannuloplasty implant adapted to be attached to the heart valve annulusin order to reshape the annulus and allow the leaflets to open and closeproperly.

The annuloplasty implant need not be attached to the implantationinstrument for being inserted to the heart valve. The implantationinstrument may provide the primary reshaping of the valve annulus. Theannuloplasty implant may then be separately inserted to permanentlyreshape the valve annulus. The correct positioning of the annuloplastyimplant is now easily achieved since the primary reshaping of the valveannulus provided by the implantation instrument clearly indicates howthe annuloplasty implant should be attached to the valve annulus.

According to a third aspect of the invention, a method is provided forrepairing a heart valve comprised of valve tissue including an annulusand a plurality of leaflets for allowing and preventing blood flow. Themethod comprises inserting an implantation instrument comprising a firstand a second support ring connected to each other to form a coiledconfiguration, said instrument being inserted such that valve tissue istrapped between the first and second support rings, attaching anannuloplasty implant to the annulus in order to reshape it, and removingthe implantation instrument.

The step of inserting the instrument may comprise temporarily reshapingthe annulus to facilitate attachment of the annuloplasty implant to theannulus. Thus, the implantation instrument will guide the positioning ofthe annuloplasty implant.

The step of inserting may further comprise inserting a first end of thefirst support ring through a portion of the valve tissue, rotating theimplantation instrument to position the first support ring on a firstside of the valve, and positioning the second support ring on anopposite second side of the valve. The first and second support ring arethus easily applied on opposite sides of the valve.

Various additional objectives, advantages and features of the inventionwill become more readily apparent to those of ordinary skill in the artupon review of the detailed description of the illustrative embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 schematically illustrates a patient with a heart shown in crosssection and a device of the present invention schematically illustratedas supporting the mitral valve.

FIG. 1A is a cross sectional view of the left ventricle showing themitral valve and a device of the invention in perspective.

FIG. 2 is a perspective view of a device according to an embodiment ofthe invention.

FIG. 3 is a cross sectional view of the device in FIG. 2.

FIG. 3A is a fragmentary perspective view, partially in cross-section,further illustrating one of the support rings shown in FIG. 3.

FIG. 3B is a fragmentary perspective view, partially in cross-section,illustrating alternate support rings according to the present invention.

FIG. 3C is a perspective view illustrating alternate support rings witha surface of the ring coated with a cushioning material.

FIG. 3D is an enlarged view of encircled portion “3D” shown in FIG. 3C.

FIGS 4A–4B are partially sectioned perspective views of the mitral valveand the device of the invention during implantation of an annuloplastyimplant of the device.

FIG. 5 is a partially sectioned perspective view showing the device ofthe invention when the implantation instrument has been turned intoposition.

FIG. 6 is a cross-sectional view illustrating primary reshaping of thevalve.

FIG. 7 is a partially sectioned perspective view showing the device whenthe annuloplasty implant is being attached to the valve annulus.

FIG. 8 is a perspective view showing the device after implantation iscompleted.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

FIG. 1 illustrates a patient 10 having a heart 12 shown in cross sectionincluding a left ventricle 14 and a right ventricle 16. The concepts ofthe present invention are suitable to be applied, for example, to amitral valve 18 which supplies blood into left ventricle 14. Mitralvalve 18, as better shown in FIG. 1A, includes an annulus 20 and a pairof leaflets 22, 24 which selectively allow and prevent blood flow intoleft ventricle 14. It will be appreciated that the term annulus tissueis used extensively throughout this disclosure in reference to thedrawings, however, the inventive principles are equally applicable whenreferring to other valve tissue such as leaflet tissue or other attachedvessel tissue. Leaflets 22, 24 are supported for coaptation by chordaetendinae or chords 26, 28 extending upwardly from respective papillarymuscles 30, 32. Blood enters left ventricle 14 through mitral valve 18and is expelled during subsequent contraction of heart 12 through aorticvalve 34. It will be appreciated that the present invention isapplicable to tricuspidal heart valves as well.

A preferred device of the present invention is shown in FIGS 2 and 3.The device comprises an implantation instrument 40 which comprises afirst and a second support ring 42, 44 assuming a coiled configurationin the form of a spiral or keyring-type configuration. Any suitablemedical grade material(s), such as medical grade metals or plastics, maybe used to form the implantation instrument 40. The device is shown incross section in FIG. 3. The implantation instrument 40 has atraditional cross sectional shape associated with a keyring. In thisembodiment flat, opposed surfaces 46 are arranged to trap valve annulustissue 20 therebetween. The opposed surfaces 46 may also be roughened inorder to improve engagement with the valve annulus 20. The roughenedsurface 46 of the first support ring 42 is illustrated further in FIG.3A. An alternate elongate support member or implantation instrument 70is shown in FIG. 3B. This embodiment has a traditional cross-sectionalshape associated with a keyring. In this embodiment flat, opposedsurfaces 72 trap valve annulus tissue 20 therebetween.

FIGS. 3C and 3D illustrate another alternate valve support member orimplantation instrument 90 in the shape of a coil or keyring. Thisembodiment also illustrates retaining members 92 in the form of smallthreaded fasteners. As shown best in FIG. 3D, a coating of softercushioning material 94. 96 may be applied to surfaces of the coil member90 which oppose one another and contact opposite sides of the valveannulus (not shown). In addition to cushioning the contact areas withthe annulus tissue, these coatings may provide additional friction toretain the instrument 90 in place.

An annuloplasty implant 50 is attached to the second support ring 44 ofthe implantation instrument 40, by means of sutures 51 or clips. Theannuloplasty implant 50 may be any type of annuloplasty ring, such asthe CG Future™ Annuloplasty System manufactured by Medtronic, Inc., theSJM Tailor® Annuloplasty Ring or the SJM Tailor® Flexible AnnuloplastyBand manufactured by St. Jude Medical, Inc., the Sovering™ manufacturedby Sorin Group, the Carpentier-McCarthy-Adams IMR ETlogix AnnuloplastyRing® or the Carpentier-Edwards Classic Annuloplasty Ring® manufacturedby Edwards Lifesciences Corporation, which annuloplasty ring may form acomplete ring-shape or an arcuate shape. The annuloplasty implant 50 isadapted to be attached to the valve annulus 20 by means of suturethreads, as will be explained in further detail below. The annuloplastyimplant 50 has a shape conforming to a desired shape of the valveannulus 20. Thus, when attached to the valve annulus 20, theannuloplasty implant 50 will reshape the valve annulus 20 to a desiredshape. The annuloplasty implant 50 is non-stretchable lengthwise, whichimplies that when attached to the valve annulus it will not allowdilatation of the annulus. However, the annuloplasty implant may beflexible to change its shape while maintaining its length to allow thenormal movements of the valve annulus 20 during a heart cycle. Theannuloplasty implant 50 may have sections of differing rigidity andflexibility to comply with the normal movements of the valve annulus 20during the heart cycle.

Referring now to FIGS 4–7, a method for repairing a heart valve by meansof the device will be described. First, access to the heart valve isachieved by conventional techniques, including arresting the heart andopening the chest. In FIG. 4A, the device is shown when being insertedto the mitral valve 18. The implantation instrument 40 connected to acarrier 52, which has an arcuate portion 53 integral with the secondsupport ring 44 and a stem 55 coupled with the arcuate portion 53, forremote control of the positioning of the carrier 52 and implantationinstrument 40. An end of the first support ring 42 is brought to acorner of the opening between the leaflets 22, 24 of the mitral valve20, as shown in FIG. 4B. The end is led through the opening and thecarrier 52 is turned 360 degrees. Thus, the first support ring 42 willbe rotated into place on one side of the valve 18, whereas the secondsupport ring 44 is placed on the opposite side of the valve 18. In thisway, the implantation instrument 40 is arranged in engagement with thevalve 18, as shown in FIG. 5.

The leaflets 22, 24 may now be drawn towards each other through thepinch of the support rings 42, 44, as illustrated in FIG. 6. Theleaflets are drawn through the pinch by means of a forceps instrument54. The support rings 42, 44 may flex away from each other to allowdrawing leaflets 22, 24 through the pinch and towards each other forpreventing the leaflets 22, 24 to slip back. The valve annulus 20 may inthis way be reshaped and be temporarily held in the new shape by meansof the implantation instrument 40. The support rings 42, 44 may haveroughened, opposed surfaces 46 to better keep the leaflets 22, 24 fromslipping through the pinch and to hold the valve annulus 20 in itsreshaped form.

The annuloplasty implant 50, which has been carried into position bymeans of the second support ring 44, may now be attached to the valveannulus 20 for achieving a permanent reshaping of the annlus 20. Since aprimary reshaping has already been made, the positioning of theannuloplasty implant 50 is facilitated. The annuloplasty implant 50 issutured to the valve annulus, as illustrated in FIG. 7, showing acompleted suture 60 attaching the annuloplasty implant 50 to the valveannulus 20 and showing a suture 62 being performed. In this way, theannuloplasty implant 50 is firmly attached to the valve annulus 20 forkeeping the valve annulus 20 in its reshaped form. The leaflets 22, 24may also or alternatively be drawn towards each other through the pinchof the support rings 42, 44 during suturing of the annuloplasty implant50.

When the annuloplasty implant 50 has been firmly attached to the valveannulus 20, the annuloplasty implant 50 is released from theimplantation instrument 40. The sutures 51 holding the annuloplastyimplant 50 attached to the second support ring 44 are cut in order torelease the annuloplasty implant 50 from the implantation instrument 40.Now, the implantation instrument 40 may be withdrawn. The carrier 52 isturned 360 degrees in order to rotate the first support ring 42 to beretracted through the opening between the leaflets 22,24. Thereafter,the carrier 52 with the implantation instrument 40 may be retracted fromthe patient. As shown in FIG. 8, the annuloplasty implant 50 is now leftin the patient holding the valve annulus 20 in a reshaped form such asto function normally.

As an alternative, the implantation instrument 40 does not carry theannuloplasty implant 50. In this case, the implantation instrument 40 isinserted into position first. This positioning of the implantationinstrument 40 may be performed as described above with reference toFIGS. 4–6. While the implantation instrument 40 is held in placemaintaining the temporary reshaping of the valve annulus 20, theannuloplasty implant 50 may be inserted to the mitral valve by means ofconventional techniques for inserting an annuloplasty ring using acarrier. The annuloplasty implant 50 is then sutured to the valveannulus in order to permanently keep the valve annulus 20 in itsreshaped form. Thereafter, the carrier used for inserting theannuloplasty implant 50 and the implantation instrument 40 may bewithdrawn leaving the annuloplasty implant 50 in the patient.

It should be emphasized that the preferred embodiments described hereinare in no way limiting and that many alternative embodiments arepossible within the scope of protection defined by the appended claims.

For example, the access to the heart valve may be achievedendoscopically. In such case, the implantation instrument 40 and theannuloplasty implant 50 need to be inserted through a narrow tube(endoscope). This implies that the implantation instrument 40 and theannuloplasty implant 50 will need to be compressed during insertion inorder to pass through the endoscope. The implantation instrument 40needs to assume its proper shape after having been passed through theendoscope. Therefore, using an endoscopic approach, the implantationinstrument 40 should preferably be formed from a shape memory material.This allows the implantation instrument 40 to be compressed and also tohave a stable shape when being applied to the heart valve. Further, theannuloplasty implant 50 needs to be flexible in order to be compressedfor the insertion through the endoscope.

1. A device for repairing a heart valve comprised of valve tissueincluding an annulus and a plurality of leaflets for allowing andpreventing blood flow, the device comprising: an implantationinstrument, comprising: a first support ring, and a second support ringconnected to said first support ring to form a coiled configuration,said first support ring configured to abut one side of the valve andsaid second support ring configured to abut an opposite side of thevalve to thereby trap a portion of the valve tissue therebetween, and anannuloplasty implant adapted to be attached to the heart valve annulusin order to reshape the annulus and allow the leaflets to open and closeproperly, said annuloplasty implant being connected to the implantationinstrument for insertion to the annulus, wherein the annuloplastyimplant is removably attached to the second support ring of theimplantation instrument such that the implantation instrument may bewithdrawn from a patient after the annuloplasty implant has beenattached to the heart valve annulus.
 2. The device according to claim 1,wherein said first and second support rings have generallytriangular-shaped cross sections.
 3. The device according to claim 1,wherein said first and second support rings are formed from a shapememory alloy.
 4. The device according to claim 1, wherein theimplantation instrument further comprises a material on at least one ofsaid first and second support rings for reducing friction between therespective rings and the valve tissue in the longitudinal direction ofthe rings.
 5. The device according to claim 1, wherein opposed surfacesof said first and second support rings are roughened to facilitateengagement with the valve tissue.
 6. The device according to claim 5,further comprising a coating of cushioning material on each of saidopposite surfaces.
 7. The device according to claim 1, wherein each ofsaid first and second support rings is formed from a fabric material. 8.The device according to claim 1, further comprising a stem, which isconnected to the implantation instrument for carrying said first andsecond support rings into position on opposite sides of the valve. 9.The device according to claim 1, wherein said first and second supportrings are adjustable in diameter to allow adjustment of the valveannulus.
 10. The device according to claim 1, wherein the annuloplastyimplant has a desired arcuate shape conforming to an arcuate shape of aportion of the annulus.
 11. The device according to claim 1, wherein theannuloplasty implant has a ring-shape conforming to the desired shape ofthe annulus.
 12. The device according to claim 1, wherein theannuloplasty implant is attached to the second support ring by means ofa removable suture.
 13. The device according to claim 1, wherein theannuloplasty implant is arranged to be attached to the annulus by meansof suture threads.
 14. A kit for repairing a heart valve comprised ofvalve tissue including an annulus and a plurality of leaflets forallowing and preventing blood flow, the kit comprising: an implantationinstrument, comprising: a first support ring, and a second support ringconnected to said first support ring to form a coiled configuration,said first support ring configured to abut one side of the valve andsaid second support ring configured to abut an opposite side of thevalve to thereby trap a portion of the valve tissue therebetween, and anannuloplasty implant adapted to be attached to the heart valve annulusin order to reshape the annulus and allow the leaflets to open and closeproperly, wherein the implantation instrument is adapted to temporarilyreshape the heart valve annulus for allowing the annuloplasty implant tobe attached to the heart valve annulus and the implantation instrumentis adapted to be withdrawn from a patient after the annuloplasty implanthas been attached to the heart valve annulus.
 15. A method for repairinga heart valve comprised of valve tissue including an annulus and aplurality of leaflets for allowing and preventing blood flow, saidmethod comprising: inserting an implantation instrument comprising afirst and a second support ring connected to each other to form a coiledconfiguration, said instrument being inserted such that valve tissue istrapped between the first and second support rings, attaching anannuloplasty implant to the annulus in order to reshape it, and removingthe implantation instrument.
 16. The method according to claim 15,wherein the step of inserting the instrument comprises temporarilyreshaping the annulus to facilitate attachment of the annuloplastyimplant to the annulus.
 17. The method according to claim 15, whereinthe step of inserting comprises inserting a first end of the firstsupport ring through a portion of the valve tissue, rotating theimplantation instrument to position the first support ring on a firstside of the valve, and positioning the second support ring on anopposite second side of the valve.